Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

YANNUZZI FUNDUS LASER LENS

K-Number: K864304 · 1986-12-15

ApplicantOcular Instruments, Inc.
Decision Date1986-12-15
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

YANNUZZI FUNDUS LASER LENS is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Instruments, Inc.. It received FDA 510(k) clearance on 1986-12-15 under 510(k) number K864304. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YANNUZZI FUNDUS LASER LENS?

YANNUZZI FUNDUS LASER LENS is a medical device that received FDA 510(k) clearance on 1986-12-15. The listed applicant is Ocular Instruments, Inc.. The 510(k) number is K864304.

When did YANNUZZI FUNDUS LASER LENS receive FDA 510(k) clearance?

YANNUZZI FUNDUS LASER LENS received FDA 510(k) clearance on 1986-12-15, under 510(k) number K864304.

Who is the listed applicant for YANNUZZI FUNDUS LASER LENS?

The FDA 510(k) record lists Ocular Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YANNUZZI FUNDUS LASER LENS?

The FDA product code for YANNUZZI FUNDUS LASER LENS is HJK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ocular Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K014170STAURENGHI WIDE FIELD SCANNING LASER LENSK012096DISPOSABLE VITRECTOMY LENSK933976MANDELKORN SUTURE LYSIS LENSK933264RITCH NYLON SUTURE LASER LENSK94142050 DEGREE HRI PRISM LENSK935302OSHER SURGICAL GONIO/POSTERIOR POLE LENS

View all 50 devices →

Related Devices (Code: HJK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201909RxSight Contact LensRxsight, Inc.K173944Endocular Viewing Lenses and Silicone RingPhakosK051630SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.K033950DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑